Two layer sterile packaging

ABSTRACT

Two layer sterile packaging for separate articles such as a catheter, disposable glove and rinse container, employing a plastic sheet folded to bring the two opposite side edges adjacent, with each end of the folded sheet sealed to form a first pouch, a semi-permeable bacteria impermeable closure sheet overlying the plastic sheet including the area in which the two opposite side edges are disposed, such closure sheet being sealed about its perimeter to the plastic sheet and being of sufficient width to form a second pouch adjacent the plastic sheet; a catheter lies in the first pouch formed by the plastic sheet and a disposable glove and rinse container lies in the second pouch whereby the package may be opened by tearing away the closure sheet to permit removal of the container and glove from the second pouch so that the glove can be donned by the user, whereupon the catheter may be removed from the first pouch formed by the plastic sheet in a sterile condition.

United States Patent [1 1 Center Dec. 16, 1975 TWO LAYER STERILE PACKAGING [75] Inventor: John L. Center, Dallas, Tex. [73] Assignee: Vicra Sterile, Inc., Dallas, Tex.

[22] Filed: Aug. 1, 1973 [21] Appl. No.: 384,697

[52] US. Cl. 206/364; 206/370; 206/438',

[51] Int. CL. B65d 83/10; A61b 19/02; B65d 31/17 [58] Field of Search 229/56; 206/364, 363, 438, 206/440, 370, 441, 63.5

[56] References Cited UNITED STATES PATENTS 3,472,369 10/1969 Schuster 206/632 3,674,195 7/1972 Stone 206/440 Primary ExaminerWilliam I. Price Assistant ExaminerDouglas B. Farrow Attorney, Agent, or Firm-Richards, Harris & Medlock [5 7] ABSTRACT Two layer sterile packaging for separate articles such as a catheter, disposable glove and rinse container, employing a plastic sheet folded to bring the two opposite side edges adjacent, with each end of the folded sheet sealed to form a first pouch, a semi-permeable bacteria impermeable closure sheet overlying the plastic sheet including the area in which the two opposite side edges are disposed, such closure sheet being sealed about its perimeter to the plastic sheet and being of sufficient width to form a second pouch adjacent the plastic sheet; a catheter lies in the first pouch formed by the plastic sheet and a disposable glove and rinse container lies in the second pouch whereby the package may be opened by tearing away the closure sheet to permit removal of the container and glove from the second pouch so that the glove can be donned by the user, whereupon the catheter may be removed from the first pouch formed by the plastic sheet in a sterile condition.

7 Claims, 5 Drawing Figures US. Patent Dec. 16, 1975 3,926,309

TWO LAYER STERILE PACKAGING This invention relates to sterile packaging of medical implements and the like, and more particularly to a two layer packaging assembly in which separate articles may be packaged in separate sterile layers to permit sequential access to the separate articles, without the necessity of breaking sterilization of the last article or articles to be unwrapped by the removal of the earlier article or articles.

The invention contemplates packaging which will provide an optimum sterile condition for the articles to be used while admitting of simple disengagement of the articles from the packaging and reducing wrapping to be disposed of to a minimum and maintaining a high storage density for reducing storage costs.

The invention has utility for a number of applications of disposable packaging of sterile articles. It is particularly well adapted to the packaging of a suction catheter with a disposable glove and a collapsible rinse container which are used in conjunction therewith. The invention will be described by Way of illustration in conjunction with such articles.

Suction catheters are used in intubation procedures in order to remove secretions which accumulate in the mouth, throat, endotracheal and tracheostomy tubes of a patient. The intubation process serves to keep these passages clear of mucous collections and, more importantly, to remove from the tracheal and lung passages materials which interfere with oxygenation of the blood. Such procedures ordinarily are used for patients who require breathing assistance. A typical hospital often has a large number of such patients, and thus a relatively large need for suction catheters to employ these procedures.

Because of infection problems, there is a need for suction catheters to be provided for single use after which they are discarded, each such catheter separately packaged in a sterile environment, and including in each package a sterile disposable glove and rinse container also to be discarded after one use. In the hospital room environment, it is most important that packaging provide ready access to the needed materials without the necessity of difficult or complicated procedures to obtain the articles in the proper sterile condition. Moreover, since the patients requiring this type of apparatus often need a very high volume of such catheters, a hospital typically must maintain a large supply of the catheters on hand. For example, some patients may require as many as fifty suction catheters during the first 24 hour period of treatment utilizing intubation procedures. Because of this large volume, the necessity to reduce storage space to a minimum in packaging such articles is often quite pressing. Moreover, as waste disposal becomes a greater problem for our society as a whole, so does it particularly with hospitals, which find it highly desirable and indeed urgently necessary to reduce the amount of waste involved in packaging of materials which they use to a minimum.

Accordingly, it is an object of this invention to provide a maximum storage density packaging system for a medical implement such as a suction catheter to be packaged in sterile form along with other articles which are needed with the implement such as a sterile glove and a collapsible rinse cup, in a package permitting sequential access to the packaged articles.

It is highly important that the packaging be manipulatable so as to maintain the highest possible degree of sterility in breaking open of the packaging and utilization of the articles within. Accordingly, it is another object of this invention to provide such articles in packaging which will provide sequential access to the articleswhile maintaining sterility. The packaging of this invention may be readily opened to provide access to a rinse container and sterile glove, without affecting the sterility of the implement on the underlying layer in the package.

This invention provides an orderly packaging scheme for such articles which simplifies and enhances the technique to be utilized in insuring sterility of the articles used in medical procedures and facilitates simplicity and rapidity of use, as well as providing for high density storage and minimizing waste packaging materials.

In many types of peel-open plastic pouches which have been utilized in the prior art, it is necessary to coil the catheters and restrain the coil in order to prevent the catheter from breaking out of the package when the package is opened, and thus possible breaking sterility. This results in a catheter which is kinked when it comes out of the package, and thus prevents problems in usage. On the other hand an extra large package can be provided to prevent the catheter from breaking sterility on opening, but this increases the amount of waste and increases the storage space required.

The prior art does disclose a type of packaging which permits relatively high density packaging of sterile articles, but which presents problems in preserving sterility of articles to be sequentially removed from the package. Such a package is disclosed in US Pat. No. 3,472,369. A plastic sheet such as polyethylene is folded over so that its sides are adjacent, and its ends are sealed to form a pouch which may be opened by separating the opposite side edges. The package is then sealed by the use of a paper peel tab along these adjacent side edges, which tab may be torn away for access to the package. The peel tab permits the package to be sterilized after assembly because it is permeable to sterilizing gases.

Unfortunately, the packaging disclosed in this patent had disadvantages if it is desired to package a number of separate articles, the sterility of which is important to the medical procedure under consideration.

For example, in the case of a suction catheter where a sterile glove is to be utilized, and a separate rinse cup provided, the opening of the package and entry by the user with an unsterilized hand to remove the glove gives unsterile contact with the edges of the pouch and with the interior of the pouch, and indeed presents the possibility of contacting the catheter itself with an unsterilized hand. The gloved hand entering the package to extract the catheter may be contaminated because the same package has already been entered by an ungloved hand. Indeed the sterility of the catheter itself may be broken simply in the procedure of extracting the glove and the rinse cup from the package.

There is provided in accordance with this invention packaging which is generally of the type shown in US. Pat. No. 3 ,472,369 utilizing a folded plastic sheet forming a pouch and having an overlying paper closure sheet, although with modifications resulting in substantial mechanical and procedural advantages over the packaging disclosed in the prior art.

In accordance with the invention, a plastic sheet is folded along two generally parallel fold lines so that two side edges of the sheet are generally adjacent, the

folded layers of the sheet being sealed together across each end to form a first pouch which may be opened by separation of the two side edges of the sheet. A semipermeable bacteria impermeable closure sheet overlies the area in which the two opposite side edges of the plastic sheet are disposed to form a second pouch adjacent the plastic sheet to receive a sterile article, such closure sheet being sealed around its perimeter to the plastic sheet; a first sterile article lies in the first pouch, and a second sterile article is disposed in the second pouch whereby the package may be opened by tearing away the closure sheet so that the second article may be readily removed from its pouch without contacting the first article or the interior or side edges of the first pouch, and the first article may thereafter be removed between the adjacent side edges of the first pouch, still in sterile condition.

For a more complete understanding of the present invention and for further objects and advantages thereof, reference may now be had to the following description taken in conjunction with the accompanying drawings, in which:

FIG. 1 is a partially exploded view of packaging formed in accordance with the present invention;

FIG. 2 is a cross-sectional view along the lines 2-2 of FIG. 1, with the package shown assembled with some portions exaggerated to permit the elements illustrated to be more easily seen;

FIG. 3 is a perspective view of the package of FIG. 1;

FIG. 4 is a perspective illustration of the package of FIG. 1 with the initial closure sheet torn back to provide access to the top layer of the packaging; and

FIG. 5 is a perspective view illustrating the removal of the medical implement from the lower layer of the packaging.

Illustrated in the drawings is a two layer sterile packaging assembly generally indicated by the reference numeral 10, to permit sequential access to separately packaged articles in order to preserve the sterility of the later unwrapped articles during removal of the earlier removed articles. A first pouch 11 is formed utilizing a plastic sheet 12 which is folded over along generally parallel folded lines .to bring opposite side edges 16 into generally adjacent relationship. The opposite side edges 16 may be brought into overlapping relationship, but preferably are disposed so that a slight gap remains between the side edges 16, as illustrated in the drawings.

The plastic sheet 12 is preferably formed from a heat sealable plastic such as polyethylene. The folded layers of the sheet 12 are sealed across each end as indicated by the stipled areas 18, so that pouch 11 is formed with ends sealed at 18 and an access opening provided along the juxtaposed side edges 16. In actual assembly of the packaging, the sealing of one end of the sheet 12 in the stipled area 18 may conveniently be formed as the last step in assembling the package, after the article or articles to be packaged have been placed in the package.

A paper closure sheet 20 lies across plastic sheet 12 including opposite side edges 16, forming in cooperation with sheet 12 a second pouch 22. Pouch 22 has sufficient width to permit ready insertion of a disposable glove and collapsible rinse container. The closure sheet 20 is preferably formed from a thin paper material which is impermeable to bacteria, but which is permeable to a sterilizing gas so that the interior of the package may be sterilized after assembly of the complete packaging with articles enclosed therein. The closure sheet 20 is bonded by convenient means such as heat sealing about its perimeter as indicated at the stipled side areas 24 and stipled end areas 26, so that a complete seal is provided for pouches 11 and 22. Once again, the seal on one of the end areas 26 bonding the closure sheet 20 to the plastic sheet 12 may conveniently be carried out as the last step in the packaging procedure, after the articles to be placed in the package have been implaced.

While the invention can be utilized in connection with a number of articles to be packaged in a sterile environment for sequential unwrapping, the drawing illustrates its utilization with a suction catheter which is packaged with a sterile glove and collapsible rinse container. The suction catheter 28 is placed in pouch 11 in an unrestrained state. It is not necessary to coil or restrain the catheter 28 in order to preserve sterility of the first pouch 11 on breaking into the package. The disposable glove 30 and collapsible rinse container 32 are shown folded and lying in the second pouch 22. The disposable glove may be any of a number available on the market, a suitable one being the disposable glove adhered to paper backing produced by Arbrook, Inc. under the trademark Dispos-a-Glove, which may be unfolded and donned by the user without contaminating the outer surface of the glove. The collapsible container 32 may be a container folded along the lines of a typical grocery sack or air sickness bag, although of a smaller size, which is storable in an essentially flat state.

In assembling the packaging illustrated, the plastic sheet 12 may first be folded and then placed against the paper closure sheet 20 in aligned relationship. The heat sealing of one end of the plastic sheet at 18 and one end of the paper closure sheet 20 to the plastic sheet 12 as illustrated by stipled area 26 at one end may be performed simultaneously with the sealing of the sides of the paper sheet 20 to the plastic sheet 12 as shown in stipled area 24. The incomplete packaging thus formed can be stored until ready for introduction of the articles for preparation of a complete package. The suction catheter 28 may be placed into pouch 11 at the unsealed end of the package, and likewise the glove 30 and container 32 placed in the second pouch 22 through the unsealed end. Thereafter, the seal of the plastic sheet to itself between layers as indicated at the stipled area 18 and the paper sheet 20 to the plastic sheet 12 as indicated by stipled area 26 can be formed simultaneously to complete the sealing of the package at the theretofore open end. Thereafter the package and contents may be placed in an environment of sterilizing gas to sterilize the package, and thereafter be purged by vacuum so that the complete sterile package is ready for shipment.

It will be appreciated that the utilization of the packaging herein described permits use of a relatively small amount of packaging space to accomplish the desired objective.

Once the article has been transported to its site of usage and is ready for use, entry into the package is performed as indicated by FIGS. 3-5. As illustrated in FIG. 3, an end of the paper closure sheet 20 extending beyond the sealed area 26 is available for grasping to tear the closure sheet 20 lengthwise of the package, thus exposing pouch 22 and making the disposable glove 30 and rinse container 32 readily accessible without contacting the interior of pouch 1 l, the catheter 28 itself, or the side edges 16 which form the pouch l1.

The glove 30 and container 32 may be removed from pouch 22. The user places the glove 30 on his hand without touching the outer surfaces of the glove, either before or after filling the rinse container 32. With the donning of glove 30, entry into the lower layer of the package at pouch 11 may proceed. The users gloved hand may be used to separate the opposite side edges 16 of the sheet 12 to provide access to pouch 11, and thus remove the suction catheter 28 for use.

Typically, the entire amount of waste materials remaining after use may be wadded into a small ball and placed in the disposable glove to provide a small and compact material to be disposed of.

Having described the invention in connection with certain specific embodiments thereof, it is to be understood that further modifications may now suggest themselves to those skilled in the art and it is intended to cover such modifications as fall within the scope of the appended claims.

What is claimed is:

1. Two layer sterile packaging for separate articles comprising:

a plastic sheet folded along two fold lines generally parallel to the two side edges of the sheet, the folded layers of the sheet being sealed together across each end to form a first pouch to which access may be had between the two side edges of the sheet, closure sheet overlying the area in which the two opposite side edges of the plastic sheet are disposed to form a second pouch adjacent the plastic sheet, such closure sheet being sealed to the plastic sheet around a perimeter encompassing at least a portion of said two opposite side edges to complete sealing of the first and second pouches from the atmosphere; at least one sterile article lying in the first pouch; and at least one sterile article lying in the second pouch whereby the package may be opened by tearing away the closure sheet so that an article in the second pouch may be readily removed from the second pouch without contacting the interior or 6 side edges of the first pouch, and the contents of the first pouch may thereafter be removed between the adjacent side edges of the first pouch.

2. The packaging of claim 1, wherein a gap is left between the two side edges of the folded plastic sheet.

3. The packaging of claim 1 wherein the two side edges of the folded plastic sheet overlap.

4. The packaging of claim 1, wherein a suction catheter lies in the first pouch and a disposable glove lies in the second pouch.

5. The combination of claim 4 wherein a collapsible cup is also positioned in the second pouch.

6. In a sterile package for a medical implement having a plastic sheet folded along two lines generally parallel to two opposite side edges of the sheet, the folded layers of the sheet being sealed together across each end to form a first pouch to which access may be had between such two opposite side edges, and a closure sheet overlying the plastic sheet including the area in which the two opposite side edges are disposed, such closure sheet being sealed to the plastic sheet around a perimeter encompassing a portion of said two opposite side edges; and a sterile implement lying in the first pouch; the improvement comprising:

the closure sheet having sufficient width that a second pouch formed by the closure sheet and the plastic sheet will readily receive a disposable glove, said second pouch containing at least one article comprising a disposable glove whereby the package may be opened by tearing away the closure sheet so that the glove may be readily removed from the second pouch without contacting the sterile implement or the interior or side edges of the first pouch, and placed on the users hand, after which the hand having the sterile glove thereon may be inserted into the first pouch to remove the implement through the longitudinal opening.

7. The combination of claim 6, wherein the implement is a suction catheter and wherein a collapsible cup is also situated in the second pouch. 

1. Two layer sterile packaging for separate articles comprising: a plastic sheet folded along two fold lines generally parallel to the two side edges of the sheet, the folded layers of the sheet being sealed together across each end to form a first pouch to which access may be had between the two side edges of the sheet, a closure sheet overlying the area in which the two opposite side edges of the plastic sheet are disposed to form a second pouch adjacent the plastic sheet, such closure sheet being sealed to the plastic sheet around a perimeter encompassing at least a portion of said two opposite side edges to complete sealing of the first and second pouches from the atmosphere; at least one sterile article lying in the first pouch; and at least one sterile article lying in the second pouch whereby the package may be opened by tearing away the closure sheet so that an article in the second pouch may be readily removed from the second pouch without contacting the interior or side edges of the first pouch, and the contents of the first pouch may thereafter be removed between the adjacent side edges of the first pouch.
 2. The packaging of claim 1, wherein a gap is left between the two side edges of the folded plastic sheet.
 3. The packaging of claim 1 wherein the two side edges of the folded plastic sheet overlap.
 4. The packaging of claim 1, wherein a suction catheter lies in the first pouch and a disposable glove lies in the second pouch.
 5. The combination of claim 4 wherein a collapsible cup is also positioned in the second pouch.
 6. In a sterile package for a medical implement having a plastic sheet folded along two lines generally parallel to two opposite side edges of the sheet, the folded layers of the sheet being sealed together across each end to form a first pouch to which access may be had between such two opposite side edges, and a closure sheet overlying the plastic sheet including the area in which the two opposite side edges are disposed, such closure sheet being sealed to the plastic sheet around a perimeter encompassing a portion of said two opposite side edges; and a sterile implement lying in the first pouch; the improvement comprising: the closure sheet having sufficient width that a second pouch formed by the closure sheet and the plastic sheet will readily receive a disposable glove, said second pouch containing at least one article comprising a disposable glove whereby the package may be opened by tearing away the closure sheet so that the glove may be readily removed from the second pouch without contacting the sterile implement or the interior or side edges of the first pouch, and placed on the user''s hand, after which the hand having the sterile glove thereon may be inserted into the first pouch to remove the implement through the longitudinal opening.
 7. The combination of claim 6, wherein the implement is a suction catheter and wherein a collapsible cup is also situated in the second pouch. 